Kornimate/medical-research-clean huggingface dataset:
an efficacy and safety study of transdermal therapeutic system (tts)-fentanyl in cancer participants with inadequately controlled pain by non-narcotic analgesics

Conditions: Pain; Cancer

Summary: the purpose of this study is to evaluate the efficacy and safety of transdermal therapeutic system (tts)-fentanyl d-trans (transdermal patch containing a drug that is put on the skin so the drug will enter the body through the skin) treatment in cancer participants of korea with inadequately controlled pain by non-narcotic analgesics (drug used to control pain) and participant's satisfaction.

this is an open-label (all people know the identity of the intervention), single-arm, multicenter (conducted in more than one hospital or medical school team work on a medical research study), prospective (study following participants forward in time) study conducted to assess the efficacy and safety of tts-fentanyl d-trans in cancer participants of korea with inadequately controlled pain by non-narcotic analgesics and for participant's satisfaction. the participants will receive the initial dose of tts-fentanyl d-trans patch releasing 12 micrograms per hour (12 mcg/hr) of fentanyl and will be increased by 12 mcg/hr or 25 mcg/hr, every 3 days depending on the participant's pain control. efficacy will primarily be evaluated by participant's satisfaction with pain treatment. participant's safety will be monitored throughout the study.

Eligibility criteria:
inclusion criteria: * participants who complains of cancer pain * participants who have taken non-opioid analgesics for the past one month for cancer pain relief purpose, but still have average 4 or higher pain level on the visual analogue scale (vas) for the last 24 hours * participants with an estimated life expectancy of at least 2 months * participants who are able to communicate with the investigator * participants who can avoid getting pregnant appropriately if there is a possibility of pregnancy during this study period exclusion criteria: * participants participating in another clinical trial * participants with a history of oversensitive reaction to a narcotic analgesic or with an existing history of drug abuse * participants who have active skin disease, avoiding application of the transdermal system * participants with a history of co2 (carbon di-oxide) retention (i.e. chronic obstructive pulmonary disease) * participants undergoing chemotherapy/radiotherapy right now or is going to get chemotherapy/radiotherapy within the study period

Keywords: pain; cancer tts-fentanyl d-trans durogesic d-trans
the effect of therapeutic play during peripheral intravenous catheterisation

Conditions: Pain; Anxiety

Summary: therapeutic play (tp) is a non-pharmacological method used in the pain management in children. this study was conducted to determine the effect of therapeutic play on children's pain, anxiety, and mothers' anxiety during peripheral intravenous catheterisation (pivc).

the hospitalisation of children due to an acute or chronic illness interrupts play, disrupts their daily routines, places them in an unfamiliar environment, forces them to encounter with unfamiliar people, exposes them to invasive procedures, and makes them suffer from pain and anxiety. peripheral intravenous catheterisation (pivc) is probably the most common procedure performed in paediatric clinics. it has been estimated that 80% of hospitalised children have a peripheral intravenous catheter in place. pivc is a painful and traumatic experience that children usually go through for the first time and frequently during the hospitalisation. this experience of children impairs effective communication between them and healthcare professionals and also causes problems in adaptation to the care and treatment process in the hospital setting. as one of the non-pharmacological pain relief methods, therapeutic play (tp) is a distraction that is defined as "the directed use of toys and materials, which can facilitate children to gain knowledge about the environment and the world they live in, to improve their perceptions thereof and to gain control, for a specific purpose". in order to call play with a child who is hospitalised as therapeutic, the play should encourage children to express their feelings and thoughts during the hospitalisation, assume an educational role in their positive or negative hospital experiences, and bring psychosocial and physical benefits. children could be told facts such as the hospitalisation, the procedures to be followed and the time when this procedure would end through therapeutic play

Eligibility criteria:
inclusion criteria: * 3-6 year-old children, * had no mental disability, * were able to communicate, * and had mothers volunteered to participate exclusion criteria: * none

Keywords: pain anxiety peripheral intravenous catheterisation therapeutic play
surgical recovery after left lateral hepatic sectionectomy: laparoscopic versus open surgery.

Conditions: Colorectal Cancer; Liver Metastasis; Liver Disease

Summary: the orange ii trial is a double blinded randomised controlled trial that will provide evidence on the merits of laparoscopic surgery in patients undergoing a left lateral hepatic sectionectomy in terms of time to functional recovery, hospital length of stay, quality of life, readmission percentage, morbidity and mortality, hospital costs, body image and cosmesis, and long term incidence of incisional hernias.

recent developments in liver surgery include the introduction of laparoscopic surgery and enhanced recovery programmes. laparoscopic surgery and enhanced recovery programmes both focus on faster recovery and consequently shorter hospital length of stay. the orange-ii trial is a prospective randomised controlled parallel group superiority trial with a double-blinded experimental and a prospective registry design to determine whether laparoscopic surgery is to be preferred over open surgery in patients undergoing a left lateral hepatic sectionectomy within an enhanced recovery programme. the experimental design produces two randomised arms; (a) open lls and (b) laparoscopic lls. an additional registry arm will be based on surgeons/patients that do not want to be randomised because they have an explicit preference for either the laparoscopic lls or for the open lls (c). the primary endpoint of the orange ii trial is time to functional recovery. the functional recovery criteria consist of adequate pain control with oral analgetics only, mobility restored to an independent level, absence of intravenous fluid administration, ability to eat solid foods and finally a normal or decreasing serum bilirubin level. a patient is fully functionally recovered when all of the five criteria are satisfied. secondary endpoints of this trial are postoperative length of hospital stay, readmission percentage, (liver specific) morbidity, quality of life, body image and cosmetic result, hospital and societal costs during one year and long-term incidence of incisional hernias. the orange-ii trial is a randomised controlled multicentre trial that will provide evidence on the merits of laparoscopic surgery in patients undergoing a left lateral hepatic sectionectomy and participating in an enhanced recovery programme.

Eligibility criteria:
inclusion criteria: * patients suitable for undergoing both laparoscopic left lateral sectionectomy as well as open left lateral sectionectomy of the liver. * able to understand the nature of the study and what will be required of them. * men and non-pregnant, non-lactating women between age 18-80. * bmi between 18-35. * patients with asa i-ii-iii exclusion criteria: * inability to give written informed consent. * patients undergoing liver resection other than left lateral hepatic sectionectomy. * patients with asa iv-v * underlying liver disease

Keywords: colorectal cancer liver metastasis benign liver disease
functional assessment of ashwagandaha root extract during weight loss

Conditions: Stress Reaction; Sleep Disturbance; Craving; Obesity

Summary: patients who are involved in a clinical protocol driven 12 week medical weight loss intervention will be randomized to receive either a placebo or 600 mg of an ashwagandha root extract. the study endpoints are primarily the patients self-reported perception of life stress and sleep quality. the working hypothesis of this study is that the addition of aschwagandha to .the medical weight loss program will improve the self-reported perception of life stress and sleep quality

during this 12-week medical weight loss program, the randomized patients will also have a baseline measurements and final measurements of blood for selected adipokines , cytokines, and telomerase measurements

Eligibility criteria:
inclusion criteria: * inclusion criteria: 1. bmi of 27 kg/m2 with comorbidities or 30 kg/m2 and above 2. perceived stress scale (pss) score of ≥ 20 at screening 3. age 18 to 70 years 4. generally healthy male or female in the judgement of the principal investigator. 5. able to attend the testing site at chp. 6. access to a computer and are able to enter information into the computer exclusion criteria: * exclusion criteria (justification of exclusion group based on demographics or their vulnerability) 1. taking chronic anti-anxiety, anti-obesity (other than phentermine) or anti-insomnia medication on a regular basis and unwilling to stop taking these classes of medications for the duration of the 12 week trial. 2. adults unable to consent 3. individuals who are not yet adults (infants, children, teenagers) 4. pregnant women 5. prisoners 6. nursing an infant 7. currently undergoing cancer treatment 8. untreated hypertension, diabetes or cardiac arrhythmias 9. dieting to lose weight in the last month 10. started within the last 14 days or plan to start taking: * birth control pills * hormone supplements (estrogen/progesterone etc) * mao inhibitors, oral corticosteroids, tricyclic antidepressants, ssri's (except fluoxetine),
safety and efficacy study of clevudine compared with clevudine and vaccine in patient with hbeag(+) chronic hbv

Conditions: Hepatitis B

Summary: a randomized, parallel, multicenter, active-controlled with 48 weeks of treatment period. patients will be randomized to receive clevudine alone for 48 weeks or clevudine for 24 weeks followed by 24 weeks of clevudine in addition to monthly hbv vaccination.the purpose of this study is to investigate efficacy of combination of clevudine and hbv vaccine over clevudine alone in patients with chronic hepatitis b infection.


Eligibility criteria:
inclusion criteria: 1. patient is between 18 and 60 2. patient is hbv dna positive with dna levels ≥ 5 x 10(6) copies/ml within 30 days of baseline. 3. patient is documented to be hbsag positive for \> 6 months. patient is hbeag positive. 4. patient has alt levels which are in the range of ≥2 x uln/l at least 2 consecutive visits, at least one month apart and bilirubin levels less than 2.0 mg/dl, prothrombin time of less than 1.7 (inr), a serum albumin level of at least 3.5 g/dl. 5. women of childbearing potential must have a negative urine (β-hcg) pregnancy test taken within 14 days of starting therapy. 6. patient is able to give written informed consent prior to study start and to comply with the study requirements. exclusion criteria: 1. patient is currently receiving antiviral, immunomodulatory, cytotoxic or corticosteroid therapy. 2. patients previously treated with interferon, lamivudine, adefovir, entecavir, telbivudine or any other investigational nucleoside for hbv infection. 3. patient has a history of ascites, variceal hemorrhage or hepatic encephalopathy. 4. patient is coinfected with hcv, hdv or hiv. 5. patient with clinical evidence of decompensated liver disease or hcc 6. ana \> 1:160 and positive anti-smooth muscle antibody as evidence of autoimmune hepatitis 7. patient is pregnant or breast-feeding. 8. patient is unwilling to use an "effective" method of contraception during the study and for up to 3 months after the use of study drug ceases. 9. patient has a clinically relevant history of abuse of alcohol or drugs. 10. patient has a significant immunocompromised, gastrointestinal, renal, hematological, psychiatric, bronchopulmonary, biliary diseases excluding asymptomatic gb stone, neurological, cardiac, oncologic or allergic disease or medical illness that in the investigator's opinion might interfere with therapy. the patient with a benign tumor, excluded if judged by an investigator that the continuation of study would be interfered by the tumor. 11. patient has creatinine clearance less than 60ml/min as estimated by the following formula: (140-age in years) (body weight \[kg\])/(72) (serum creatinine \[mg/dl\]) \[note: multiply estimates by 0.85 for women\]
short-term effectiveness of ultrasound-guided corticosteroid hydrodissection

Conditions: Carpal Tunnel Syndrome

Summary: aim: steroid injections are remarkably effective as a treatment for carpal tunnel syndrome (cts) in the short term. the aim of this study was to determine whether hydrodissection would provide an additional clinical effect when used along with a corticosteroid in the short term. methods: a prospective cohort of patients with cts were retrospectively evaluated. 28 patients were selected randomly who received ultrasound (us)-guided triamcinolone hydrodissection (3 ml) as intervention group and received us-guided triamcinolone injection (1 ml) as control group, from the data (case-control ratio 1:1). outcome measures were the boston carpal tunnel questionnaire (bctq), hand grip strength (hgs), fhe cross-sectional area (csa) of the median nerve and short form 12 (sf-12). assessments were recorded at baseline, 1 and 4 weeks after injection.

background: steroid injections are remarkably effective as a treatment for carpal tunnel syndrome (cts) in the short term. aim: to determine whether hydrodissection would provide an additional clinical effect when used along with a corticosteroid in the short term. methods: a prospective cohort of patients with cts were retrospectively evaluated. 28 patients were selected randomly who received ultrasound (us)-guided triamcinolone hydrodissection (3 ml) as intervention group and received us-guided triamcinolone injection (1 ml) as control group, from the data (case-control ratio 1:1). outcome measures were the boston carpal tunnel questionnaire (bctq), hand grip strength (hgs), fhe cross-sectional area (csa) of the median nerve and short form 12 (sf-12). assessments were recorded at baseline, 1 and 4 weeks after injection.

Eligibility criteria:
inclusion criteria: 1. aged between 18-65 2. clinically diagnosed with cts 3. electrophysiologically confirmed mild-to-moderate cts 4. having typical cts symptoms for at least 3 months 5. not benefiting from splinting and resting. exclusion criteria: 1. electrophysiologically diagnosed with severe cts 2. surgery history for cts 3. presence of metabolic, endocrine and neoplastic disorders 4. presence of other neurological disorders (such as plexopathy, cervical radiculopathy, proximal median or ulnar neuropathy, polyneuropathy and mononeuritis multiplex)

Keywords: carpal tunnel syndrome ultrasonography hydrodissection steroid injection
functional chewing gum in reduction of gingival inflammation

Conditions: Gingivitis

Summary: the aim of this prospective randomized 3-month double-blinded single center study is to determine whether a chewing gum device with food additive chitosan, will aid in reducing gingival inflammation by supplementing traditional tooth brushing and flossing measures. patients with mild to moderate gingivitis will be identified and enrolled in this investigation. all enrolled subjects will receive baseline oral hygiene brushing instructions and a baseline clinical examination of the gingiva. the test group will utilize the test chewing gum three times a day for a minimum 20-30 minutes duration; the control group will receive a placebo gum and use it in a similar manner. we will examine whether daily use of a functional chewing gum enhances improvements to brushing and flossing.

periodontal disease remains a prevalent and preventable disease in man. plaque bacterial biofilm remains the primary etiologic agent of disease; colonization of non-shedding tooth surfaces greatly contributes to initiation and progression of gingivitis, for example. although there are currently available chemotherapeutic agents to supplement daily oral hygiene measures, one continuous issue is patient compliance. chewing gum represents a unique delivery device for not only drugs and other agents, but food additives that might aid in reducing bacteria plaque colonization on tooth surfaces. for example, chitosan and chitosan-related food additive preparations have been shown to have some antimicrobial-like properties, possibly in the disruption of bacterial colonization (not -cidal). note: all ingredients of the "test" chewing gum, and the placebo chewing gum, are generally regarded as safe ("gras" label by the food and drug administration), as they are common food components. for example, chitosan is listed in the gras database (https://www.accessdata.fda.gov/scripts/fdcc/?set=scogs). see item grn no. 397. this study aims to determine whether adjunctive use of functional chewing gum will improve gingival inflammation status-retaining clinical gains initiated by professional tooth cleaning and at home brushing over a 12 week period in gingivitis patients. eligibility criteria and outcome measures are described in the next section.

Eligibility criteria:
inclusion criteria: * mild-moderate gingivitis * minimum of 20 natural teeth exclusion criteria: * significant alveolar bone loss as evidenced by bite-wings (\>3.0 mm cementoenamel junction to bone) * requirement for antibiotic pre-medication prior to dental procedures * systemic antibiotic use in past 14 days to current. * use of oral contraceptives * use of anti-inflammatory (nsaids) or in past 14 days. * use of anticoagulant therapy or in past 14 days. * poorly controlled diabetes (hba1c \> 7.9%)\* * smoking * pregnancy * use of any oral rinses such as, but not limited to chlorhexidine, essential oils, cetylpyridinium chloride during the study.

Keywords: gingivitis
german cardiac arrest registry

Conditions: Out-of-hospital Cardiac Arrest

Summary: in germany, 70.000 to 100.000 patients suffer from out-of-hospital cardiac arrest (ohca) every year. more than half of these are due to cardiac causes. despite the medical progress over the last decades, rates of survival with good neurological outcome remain low. for many below-mentioned issues, no adequate evidence from randomized trials is available. therefore, a systematic and standardized recording of the pre-clinical, clinical and post-clinical treatment course and of the clinical outcomes of ohca patients is essential to improve patient care. aim of the german cardiac arrest registry (g-car) is to achieve a better understanding of the disease entity, leading to an optimized treatment of ohca patients. the recorded data include information on demographic and psychosocial aspects, course of the disease, clinical, laboratory and other examinations as well as treatment modalities in patients with ohca due to a cardiac cause.


Eligibility criteria:
inclusion criteria: * patients with out-of-hospital cardiac arrest with assumed cardiovascular cause exclusion criteria: * rejection of register participation by patient or legal representative

Keywords: out-of-hospital cardiac arrest ohca resuscitation cardiac arrest center acute care medicine intensive care post-resuscitation care
a study to assess the efficacy and safety of emicizumab in participants with type 3 von willebrand disease

Conditions: Von Willebrand Disease, Type 3

Summary: this is a phase iii, multicenter, open-label clinical study designed to evaluate the efficacy, safety, pharmacokinetics, and pharmacodynamics of emicizumab prophylaxis in participants aged 2 years and above, who have been diagnosed with type 3 von willebrand disease (vwd). participants on prior standard of care (soc) on-demand therapy will be assessed via a randomized comparison (arm a - emicizumab prophylaxis and arm b - continuation of soc on-demand therapy), while participants on prior soc prophylactic therapy (arm c - emicizumab prophylaxis) will be assessed via intra-participant analysis with data obtained from the preceding non-interventional study (nis), wp45335 (nct06883240).


Eligibility criteria:
inclusion criteria: * confirmed diagnosis of type 3 von willebrand disease (vwd), based on medical records * preexisting medical record verifying the status of von willebrand factor (vwf) inhibitor (positive or negative, including titer if available) * adequate hematologic, hepatic, and renal function * for participants of childbearing potential: agreement to remain abstinent or adhere to the contraception requirements additional inclusion criteria for arms a and b: * documented previous use of on-demand therapy with intermittent (less than once a week) on-demand soc therapy for vwd * having ≥2 treated bleeds (except menstrual bleeds) with factor concentrate within 24 weeks prior to enrollment additional inclusion criteria for arm c: * documented and confirmed previous use of soc prophylactic therapy for vwd (1-3 times weekly, as per prescribed dose) as described in the eligibility of study wp45335 * have completed all study requirements as defined in the wp45335 protocol for at least 24 weeks exclusion criteria: * inherited or acquired bleeding disorder other than congenital type 3 vwd * history of gastrointestinal bleeding within 18 months prior to enrollment, or any previous diagnosis of angiodysplasia * history of intracranial hemorrhage * previous or current treatment for thromboembolic disease or signs of thromboembolic disease * other conditions (e.g., certain autoimmune diseases) that may increase risk of bleeding or thrombosis * history of clinically significant hypersensitivity associated with monoclonal antibody therapies or components of the emicizumab injection * use of systemic immunomodulators (e.g., interferon) at enrollment or planned use during the study, with the exception of anti-retroviral therapy